TAASS-Traumeel Ointment and Gel Compared With a Topical NSAID in Athletes With Acute Ankle Sprain

Phase 3

Completed

• Conditions: Sprain of Ankle
• Interventions: Drug: Traumeel S ointment; Drug: Traumeel S gel; Drug: Diclofenac gel

• Registration Number: NCT01066520
• Lead Sponsor: Biologische Heilmittel Heel GmbH

Brief Summary

The objective of this study is to determine the efficacy of Traumeel S (both ointment and gel) compared to another antiinflammatory drug called Diclofenac in patients with a sprained ankle.

Detailed Description

Study objective is the confirmatory proof of efficacy for Traumeel® S topical treatment, both ointment and gel, as compared to diclofenac topical treatment for patients with ankle sprain. In addition tolerability/safety of both drug preparations is to be compared, so that the benefit-risk relation can be determined.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2010-02-09
• Study First Submitted QC: 2010-02-09
• Study First Posted: 2010-02-10
• Primary Completion: 2011-09
• Study Completion: 2012-03
• Results First Submitted: 2013-02-18
• Results First Submitted QC: 2013-10-15
• Status Verified: 2013-12
• Results First Posted: 2013-12-09
• Last Update Submitted: 2013-12-09
• Last Update Posted: 2014-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 449

Inclusion Criteria

Not provided

Exclusion Criteria

• Similar injury affecting the same joint within the past 6 months
• bilateral ankle injury
• bed rest, hospitalization, surgery use of a non-removable rigid cast
• Clinically important abnormality for screening laboratory tests
• Debilitating acute or chronic illness
• Use of corticosteroids in the previous 8 weeks, any analgesics in the previous 6 hours, or 24 hours in case of long-acting NSAID, COX-2 specific inhibitors, or tramadol
• History of sensitivity to any component of the study drugs
• Unwilling or unable to comply with all the requirements of the protocol
• Participation in other studies within 4 weeks prior to study entry and or during the study participation
• Current substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of the study result

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traumeel S ointment	Traumeel S ointment	Traumeel S ointment 2 g, 3 times daily topical during 14 days
Traumeel S gel	Traumeel S gel	Traumeel S gel 2 g, 3 times daily topical during 14 days
Diclofenac gel	Diclofenac gel	Diclofenac gel 2 g, 3 times daily topical during 14 days

Primary Outcome Measures

Name	Time	Method
Patient's Assessment of Ankle Pain (VAS)- Absolute Value Decrease on Day 7	From baseline (day 1) visit to day 7	Pain evaluated by a 100 mm visual analogue scale (VAS) where 0 means no pain and 100 means the highest, unbearable pain. The absolute values of VAS have been the basis of analysis.; The highest is the change in negative, the better are the results in absolute values.
Change of the Foot and Ankle Ability Measurement (FAAM), Activity of Daily Living Subscale (ADL) From Baseline to Day 7	Day 1 to day 7	The Foot and Ankle Ability Measure (FAAM) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments. The Foot and Ankle Ability Measure is a 29-item questionnaire divided into two subscales: the Foot and Ankle Ability Measure, 21-item Activities of Daily Living Subscale and the Foot and Ankle Ability Measure, 8-item Sports Subscale.; Each item is scored on a 5-point Likert scale (4 to 0) from 'no difficulty at all' (score 4), ´slight difficulty´, ´moderate difficulty´, éxtreme difficulty´ to 'unable to do' (score 0). Responses marked as ´not applicable´were not counted.; Item score totals, which range from 0 to 84 for the ADL subscale and 0 to 32 for the Sports subscale, were transformed to percentage scores. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction.
Patient's Assessment of Ankle Pain (VAS)- Percentage Decrease on Day 7	From baseline (day 1) visit to day 7	Pain evaluated by a 100 mm visual analogue scale (VAS) where 0 means no pain and 100 means the highest, unbearable pain. The absolute values of VAS have been the basis of analysis.; The highest is the change in negative, the better are the results in percentages.

Secondary Outcome Measures

Name	Time	Method
FAAM ADL Subscale	Day 1 to 4, 14, 42
FAAM Sports Subscale	Day 1 to 4, 7, 14, 42
Swelling ('Figure-of-eight')	Day 1 to 4,7,14
Physician's Assessment of Normal Function/Activity (5-point-scale)	Day 1 to 4, 7, 14, 42
Time to Normal Function (Training/Sports)	Day 1 to 4, 7, 14, 42
Global Judgment of Efficacy	Day 14

Trial Locations

Locations (1)

MEDYR Medicina Deportiva y Rehabilitación; 🇪🇸 Madrid, Spain